Appendix 1 - BioMed Central

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Appendix 1
Construction of Risk Adjusted Control Charts.
The following notation and formulae are used for the charts.
Yij is the outcome for patient j in sample i . If the patient dies, Yij  1 and if the patient
survives, Yij  0 . The estimate of the probability of patient death provided by the risk
adjustment tool is ˆ ij so the estimate of the probability of survival is 1  ˆ ij

E – O Chart
For a series of patient series, the value for the cumulative E – O statistic C at patient n
is
n
Cn   (ˆ j  Y j )
j 1

Risk Adjusted p Chart
The expectation of the outcome of each patient Ê Yij  is estimated by the risk
adjustment model:
Eˆ Yij   ̂ ij
The variance of that estimate is approximately
v̂ar Yij   ˆ ij 1  ˆ ij 
The observed mortality rate Ri for sample i is
Ri 
Y
ij
ni
and the predicted or expected mortality rate, ÊRi  is
Eˆ Ri  
 ˆ
ni
ij
The variance of the observed mortality rate,
 v̂arY 
ni
v̂ar Ri  
ij
j 1
ni2
 ˆ 1  ˆ 
ni

j 1
ij
ij
ni2
The RA p chart compares R i to ÊRi  with control limits calculated around ÊRi  .
The control limits are defined as multiples of the standard deviation (the square root
of the variance). Let a be the number of standard deviations, then
CLi  Eˆ Ri   a. v̂ar Ri 
 ˆ 1  ˆ 
ni
CLi

 ˆ

ni
ij
 a.
j 1
ij
ij
ni2
Chart Design and Parameter Choice.
Under plausible clinical scenarios, the width of the control limits, the number of cases
and the casemix of the population under analysis are the important determinants of the
sensitivity and specificity of the risk adjusted p chart. These are common
considerations for design and parameter choice for any of the risk adjusted control
charts. Although the ICU population represents a diverse range of diagnosis, death in
ICU is relatively common and occurs in roughly 10 - 35% of patients. These charts
are robust and more suitable under these conditions, than for monitoring for rate
events, such as in cardiac surgery (mortality rate: 1 – 5%) and population surveillance,
in the “Shipman” detection scenario.
The control limits are specified at 2 standard deviations above and below the expected
mortality rate. The average number of cases admitted before a false alarm (false
positive) and before a true signal (true positive) can be examined by the calculating
the average run length to signal across a plausible range of clinical scenarios of better
or worse performance. Performance of the charts can be examined by using
approximations of distribution, by simulation or by exact methods. An acceptable
chart design can be chosen, and the effect of repeated analysis can be accounted for.
It is convenient to consider clinical scenarios as changes in risk of death in terms of an
altered odds ratio (OR) where it is the odds of death rather than the absolute risk of
death that changes.
 ijA
OR 
ˆ ij
1   ijA
1  ˆ ij
The performance of a control chart is assessed in terms of average run length incontrol (OR = 1) where the model predictions match the observed outcomes.
Similarly where the system is out-of-control (OR ≠1) the model predictions are either
above or below the observed mortality rate.
A computer simulation was used to determine the way a chart would perform, and
whether it would be clinically useful. To do this, patients are chosen at random with
replacement from a relevant case mix in blocks. To design a chart for RBH ICU, the
historical casemix was used, and the consequences of patient blocks of 10, 20, 30, 50,
70 and 100 cases were examined. Simulated outcomes were allocated as a series of
Bernoulli trials, based on specified OR and the out-of-control risk of death  ijA . For
Figure A1, the average run length is expressed in average number of cases before an
“observed” mortality rate of a sample falls outside the control limits. Five thousand
simulations were performed at each value for OR in the range 0.5 – 2, in increments
of 0.25.
The average run length of each block size with 2 standard deviation control limits is
approximately 20 times the block length when the model is accurately predicting risk
of patient death, ie OR = 1. Thus the larger the size of the samples, the more patients
you will admit before a false alarm. However, the larger block sizes also impose a
delay before detection of altered odds of death, where the risk adjusted mortality
performance has risen or fallen compared to the predicted mortality. For a block size
of 30 patients, the false alarms will occur on average of 897 patients or every 2 years
at the RBH. However, an increase of odds of death of 50% will evoke a signal after
183 patients or by the 6th month on average. For samples of 10 patients, false alarms
occur approximately annually, though 50% increase in odds of death will be not be
detected much more rapidly at 179 patients. In contrast blocks of 100 patients will
signal falsely on average every 5 years (2184 patients), but will detect a 50% increase
in odds of death on average at about 9 months (261) patients.
As a compromise between false alarm rate, and ability to detect true differences in
mortality rate, block size of 30 patients was chosen.
Figure A1: Average Run Length for Risk Adjusted p Chart
5000 Simulations performed on Cases from Royal Berkshire Hospital Intensive Care Unit
Sample sizes of 10, 20, 30, 50 70 and 100 patients, Control limits set at +/- 2 standard deviation
Average Run Length in Patients
2500
2000
1500
1000
100 patients
500
10 patients
0
0
0.5
1
1.5
Altered Odds Ratio
2
2.5
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